Zetonna

ZETONNA- ciclesonide aerosol, metered
Covis Pharma

1 INDICATIONS AND USAGE

1.1 Treatment of Allergic Rhinitis

ZETONNA® (ciclesonide) Nasal Aerosol is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis in adults and adolescents 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 Administration Information

Administer ZETONNA by the intranasal route only. Prior to initial use, ZETONNA must be primed by actuating three times. If ZETONNA is not used for ten consecutive days, it must be primed by actuating three times. If ZETONNA is dropped, the canister and actuator may become separated. If this happens, reassemble ZETONNA and test spray once into the air before using. Illustrated patient’s instructions for proper use accompany each package of ZETONNA.

2.2 Allergic Rhinitis

Adults and Adolescents (12 Years of Age and Older): The recommended dose of ZETONNA is 1 actuation per nostril once daily (37 mcg per actuation). The maximum total daily dosage should not exceed 1 actuation in each nostril (74 mcg per day).

3 DOSAGE FORMS AND STRENGTHS

ZETONNA Nasal Aerosol is provided at strength of 37 mcg per actuation strength containing 60 actuations per canister.

4 CONTRAINDICATIONS

ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA [see Warnings and Precautions (5.3) ].

5 WARNINGS AND PRECAUTIONS

5.1 Local Nasal Effects

Epistaxis and Nasal Ulceration: In clinical trials of 2 to 26 weeks in duration, epistaxis was observed more frequently in patients treated with ZETONNA than those who received placebo. In the 26-week open-label extension of the perennial allergic rhinitis trial, nasal ulceration was identified in 4 of 824 patients administered ZETONNA (148 mcg). [see Adverse Reactions (6) ]

The occurrence of local nasal adverse events was further evaluated in a separate, postmarketing 26-week randomized, open-label, active-controlled nasal and ocular safety trial conducted in patients with perennial allergic rhinitis. In this study epistaxis was observed in 6% of patients treated with ZETONNA and nasal ulceration was identified in 3 of 367 patients administered ZETONNA. [see Adverse Reactions (6) ]

Nasal Septal Perforation: Nasal septal perforation has been reported in patients following the intranasal application of ZETONNA. Three short-term placebo-controlled trials (2 weeks) and one long-term (26 weeks with placebo control and 26 weeks open-label extension without placebo control) trial were conducted in patients with seasonal and perennial allergic rhinitis. Nasal septal perforations were reported in 2 patients out of 2335 treated with ZETONNA compared with none of 892 treated with placebo. No nasal septal perforations were reported in 367 patients treated with ZETONNA in a postmarketing 26-week, open-label, active-controlled trial in patients with perennial allergic rhinitis. [see Adverse Reactions (6) ]

Before starting ZETONNA conduct a nasal examination to ensure that patients are free of nasal disease other than allergic rhinitis. Periodically monitor patients with nasal examinations during treatment for adverse effects in the nasal cavity. If an adverse reaction (e.g. erosion, ulceration, perforation) is noted, discontinue ZETONNA. Avoid spraying ZETONNA directly onto the nasal septum.

Candida Infection: In clinical trials with another formulation of ciclesonide, the development of localized infections of the nose or pharynx with Candida albicans has occurred. If such an infection develops with ZETONNA, it may require treatment with appropriate local therapy and discontinuation of ZETONNA.

Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septal ulcers, nasal surgery, or nasal trauma should not use ZETONNA until healing has occurred.

5.2 Glaucoma and Cataracts

Nasal and inhaled corticosteroids may result in the development of glaucoma and cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, or cataracts.

5.3 Hypersensitivity

ZETONNA is contraindicated in patients with a known hypersensitivity to ciclesonide or any of the ingredients of ZETONNA. Cases of hypersensitivity reactions following administration of ciclesonide with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported.

5.4 Immunosuppression

Patients who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease or prior corticosteroid treatment to the risk is also not known. If a patient is exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If a patient is exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information). If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; or in patients with untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections; or ocular herpes simplex because of the potential for worsening of these infections.

5.5 Hypothalamic-Pituitary-Adrenal Axis Suppression

Hypercorticism and adrenal suppression may occur when intranasal corticosteroids, such as ZETONNA, are used at higher than recommended dosages or in susceptible individuals at recommended dosages. If such changes occur, the dosage of ZETONNA should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

5.6 Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely (e.g., via stadiometry) in pediatric patients receiving ZETONNA. [see Pediatric Use (8.4) ]

6 ADVERSE REACTIONS

Systemic and local corticosteroid use may result in the following:

Epistaxis, ulcerations, nasal septal perforations, Candida albicans infection, impaired wound healing [see Warnings and Precautions (5.1) ]
Glaucoma and cataracts [see Warnings and Precautions (5.2) ]
Immunosuppression [see Warnings and Precautions (5.4) ]
Hypothalamic-pituitary-adrenal (HPA) axis effects, including growth reduction [see Warnings and Precautions (5.5, 5.6), Use in Specific Populations (8.4) ]
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